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Radiofrecuency and Supervised Exercise Versus Supervised Exercise in the Treatment of Patellofemoral Pain Syndrome.

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diathermy
Supervised knee exercises
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring patellofemoral pain syndrome, knee pain, diathermy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with patellofemoral pain syndrome more than 6 months old.
  • Have an age between 18 years and 50 years.
  • Adult patients with anterior knee pain were referred by a primary care physician at a public health center in southern Spain. Those participants with a self-reported pain intensity = 30 mm on the Visual Analog Scale (VAS) and a score <45 points in personal psychology The Apprehension Scale (PPAS) [bathrobe 2017], were invited to participate. The PPAS is a valid, reliable and easy-to-use tool for assessing the apprehension of subjects to receive electrical stimulation therapy [bathrobe 2005].

Exclusion Criteria:

  • Any contraindication for the use of MDR
  • Present cognitive alterations.
  • Have undergone conservative or surgical treatment of the knee in less than 6 months.
  • Having received injections of corticosteroids or hyaluronic acid; impaired cognition or communication; and be involved in an ongoing medical-legal dispute.

Sites / Locations

  • Centro de Salud San José de la Rinconada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diathermy

Control

Arm Description

Participants that receive 10 sessions of radiofrequency diathermy of 12 minutes of duration

Participants that perform supervised exercises for three weeks

Outcomes

Primary Outcome Measures

Knee pain
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain
Knee pain
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain

Secondary Outcome Measures

Knee functional disability
The functional disability, quantified by means of the tests: Kujala Score. This score goes from 0 (high disability) to 100 (no disability)
Knee functional disability
The functional disability, quantified by means of the tests: Kujala Score. This score goes from 0 (high disability) to 100 (no disability)
Knee function
Functional Scale of the Lower Extremity (LEFS). The score goes from 0 (low function) to 80 (great function)
Knee function
Functional Scale of the Lower Extremity (LEFS). The score goes from 0 (low function) to 80 (great function)
Knee flexion range of movement
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Knee flexion range of movement
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Knee extension range of movement
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Knee extension range of movement
Active knee joint range of movement. Knee range of movements goes from -10º to 150º

Full Information

First Posted
August 25, 2020
Last Updated
October 3, 2020
Sponsor
University of Jaén
Collaborators
University of Seville, Andaluz Health Service, Universidad de Extremadura
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1. Study Identification

Unique Protocol Identification Number
NCT04538508
Brief Title
Radiofrecuency and Supervised Exercise Versus Supervised Exercise in the Treatment of Patellofemoral Pain Syndrome.
Official Title
Short Term Efficacy of the Combination of Radiofrecuency Diathermy and Supervised Exercise Versus Supervised Exercise Alone in the Treatment of Patellofemoral Pain Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
Collaborators
University of Seville, Andaluz Health Service, Universidad de Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will analyze the effects of a non-invasive radiofrequency diathermy device added to knee exercises on the symptoms of patellofemoral pain syndrome. For this aim, a randomized clinical trial will be carried out with a control group that will perform supervised exercises and an experimental group that will add radiofrequency diathermy to supervised exercises. Diathermy treatment will be performed along three weeks, ten treatment sessions in total, while supervised exercises will be performed daily. Outcomes to measure will include pain, knee function and quality of life
Detailed Description
At first, a meeting will be held with the patients under study where they will be informed and any doubts that may arise in relation to the investigation will be resolved. In addition, the correct adaptation of these to the inclusion and exclusion criteria of our study will be verified. Subsequently, they will be given individually the informed consent prepared expressly for the present study, the doubts arising with respect to this one will be resolved and their signature will proceed. At this time, and individually again, we will proceed to the development of the Clinical History of Physiotherapy where only the information necessary for our study will be collected. To emphasize in this point that the participants will grant their consent for the treatment of the data obtained for scientific purposes, according to the legal norms. Next, the patients will be randomly assigned to two groups: control group and experimental group. The randomization of the sample was done through the EPIDAT software in version 3.1 between the Experimental Group and the Control Group. Subsequently, the evaluations and measurements of the study variables will be carried out by the research team. CONTROL GROUP: them will be provided exclusively therapeutic exercises protocol that you must be performed supervised by a physiotherapist following a daily activity for three weeks. EXPERIMENTAL GROUP: After the initial evaluation, the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week, three sessions on alternate days in the second week and two sessions on alternate days in the third week (3 weeks in total), applying the monopolar dielectric diathermy by radiofrequency in the anterior aspect of the knee, in dynamic application in one of the members: affect or randomized (uni or bilateral pathology, respectively). This diathermy will be combined with the same supervised therapeutic exercise program of the control group. The treatment is administered with a pulsed non-invasive radiofrequency device with 30V peak power along 12 minutes, with a dose submitis (grade I) for three weeks. The first week, daily treatment will be perform from Monday to Friday, second week on Monday, Wednesday and Friday and the third week on Monday and Thursday. After the tenth treatment session, all the measurements will be repeated following the same environmental conditions as at the beginning and by the evaluators themselves to the components of both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
patellofemoral pain syndrome, knee pain, diathermy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will not be aware about the treatment any participants will/had received
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diathermy
Arm Type
Experimental
Arm Description
Participants that receive 10 sessions of radiofrequency diathermy of 12 minutes of duration
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants that perform supervised exercises for three weeks
Intervention Type
Device
Intervention Name(s)
Diathermy
Intervention Description
10 sessions of 12 minutes of radiofrequency diathermy at the anterior surface of the knee, in constant movement
Intervention Type
Other
Intervention Name(s)
Supervised knee exercises
Intervention Description
Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.
Primary Outcome Measure Information:
Title
Knee pain
Description
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain
Time Frame
Baseline
Title
Knee pain
Description
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain
Time Frame
Three weeks after there first session of treatment
Secondary Outcome Measure Information:
Title
Knee functional disability
Description
The functional disability, quantified by means of the tests: Kujala Score. This score goes from 0 (high disability) to 100 (no disability)
Time Frame
Baseline
Title
Knee functional disability
Description
The functional disability, quantified by means of the tests: Kujala Score. This score goes from 0 (high disability) to 100 (no disability)
Time Frame
Three weeks after there first session of treatment
Title
Knee function
Description
Functional Scale of the Lower Extremity (LEFS). The score goes from 0 (low function) to 80 (great function)
Time Frame
Baseline
Title
Knee function
Description
Functional Scale of the Lower Extremity (LEFS). The score goes from 0 (low function) to 80 (great function)
Time Frame
Three weeks after there first session of treatment
Title
Knee flexion range of movement
Description
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Time Frame
Baseline
Title
Knee flexion range of movement
Description
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Time Frame
Three weeks after there first session of treatment
Title
Knee extension range of movement
Description
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Time Frame
Baseline
Title
Knee extension range of movement
Description
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Time Frame
Three weeks after there first session of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with patellofemoral pain syndrome more than 6 months old. Have an age between 18 years and 50 years. Adult patients with anterior knee pain were referred by a primary care physician at a public health center in southern Spain. Those participants with a self-reported pain intensity = 30 mm on the Visual Analog Scale (VAS) and a score <45 points in personal psychology The Apprehension Scale (PPAS) [bathrobe 2017], were invited to participate. The PPAS is a valid, reliable and easy-to-use tool for assessing the apprehension of subjects to receive electrical stimulation therapy [bathrobe 2005]. Exclusion Criteria: Any contraindication for the use of MDR Present cognitive alterations. Have undergone conservative or surgical treatment of the knee in less than 6 months. Having received injections of corticosteroids or hyaluronic acid; impaired cognition or communication; and be involved in an ongoing medical-legal dispute.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Albornoz-Cabello, PhD
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud San José de la Rinconada
City
San José de la Rinconada
State/Province
Seville
ZIP/Postal Code
41300
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participants did not allow to share their data

Learn more about this trial

Radiofrecuency and Supervised Exercise Versus Supervised Exercise in the Treatment of Patellofemoral Pain Syndrome.

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